Mohammed Saif Shaikh
Lead Associate - Global Drug Regulatory Affairs
- Role
- Lead Associate at Genpact
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Mohammed Saif Shaikh
Senior Global Drug Regulatory Affair Associate, with 9.5+ Year of experience in Drug…
Experience
Lead Associate
Feb 2023 — Present · Mumbai, IN
Working for Global Regulatory filing by creating eCTD structure for Novel Drugs (NDA/BLA/MAA/BMF/DMF/SPL etc.) in US, EMA and other ROW countries• Publish, review, submission and archival of eCTD/CTD/ACTD (including Module1 to 5) and paper submissions using Publishing Tool includes;• eSubmission Preparation (Bookmarking; hyperlinking; ensuring PDF is asper HA guidelines)• Submission level publishing (Including Module 1 to 5)• Submission QC• Manage lifecycle of products for all in-house and outsourced activities• Validate and QC of incoming and outgoing regulatory data/documents/product• Archival of other necessary submissions and/or documents to ensure that all regulatory activities globally are working smoothly• Support, maintain and update CTD authoring templates• Updating Monthly Tracker in PowerBI Dashboard for Governance meeting.
Education
Savitribai Phule Pune University
Bachelor's Degree, Pharmaceutics and Drug Design
2010 — 2013
H K College of Pharmacy, Jogeshwari, Mumbai.
Master’s Degree, Pharmaceuticals
2013 — 2015
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